Suicidal Ideation and/or Behavior in Research Protocols

Summary

This guidance provides directions for researchers using measures that involve questions related to suicidal ideation. Research shows that asking questions related to suicidal ideation (SI) does not increase suicidal risk; however, research studies or surveys that inquire about SI require additional monitoring of responses to ensure the safety of participants during the study.

Full Description

When Submitting the Protocol:

If the researcher needs to include questionnaires or other measures that will cover SI, the researcher must include in their protocol submission why the measures are necessary and describe the methods which may identify SI in research participants. The details should be explained under Study Purpose/Design, Adverse Events, Risks/Discomforts, and/or other sections as appropriate. The “Debriefing Script” should include how the SI endorsement will be addressed with the participant.

The study protocol should include a risk mitigation plan depending on how quickly the researcher can respond to the participant.

Regardless of either option A or B, participants should be given access to a list of local, state, and national resources that they can utilize to seek help

• Option A, If the participant’s responses will be monitored and answers can be linked to the participant:
  • IRB Application:
    • Researchers must explain how they will contact the participant to assess the level and immediacy of suicide risk
    • A detailed safety plan should be attached to the protocol
    • Specific research personnel that are qualified to assess and/or create a safety plan must be identified with their qualifications described
    • Describe what additional support or resources will be offered to the participant
  • Consent
    • The informed consent should state that confidentiality may not be kept if the participant discloses thoughts of suicide, self-harm or harm to others
    • Sample language is provided below option B (see below).
• Option B, If the participant’s responses will be NOT monitored and/or answers ARE NOT linked to the participant:
  • IRB Application
    • Researchers must explain why follow up with specific participants cannot be done
    • The explanation should include why the investigators believe such individually identifiable assessment is not necessary (risk-wise) or feasible (e.g. online survey programmed to collect anonymous responses would not allow for ‘real-time’ assessment of participants’ answers or follow-up if concerns were to be identified.)
    • If participants are not at high risk for SIB and will not be asked questions about intent, plan, and/or means to commit suicide, this should be specified in the explanation that there is no individual identification of/safety plan for participant responses.
  • Consent:
    • Researchers should inform participants in the consent that the responses will not be monitored. Sample language is provided below.

Sample Consent Language

Option A

• Procedures: If you tell us that you are thinking about hurting yourself or others, the research staff may ask you more questions. Depending on how intense your thoughts are or how much you feel like hurting yourself or others, the research staff may give you referrals for treatment, work with you to contact your personal doctor, trusted family member, or therapist to discuss your thoughts of harming yourself. We may need to work with you on a plan that might include getting you to a medical facility for safety.
• Confidentiality: There are some cases in which a researcher is obligated or authorized by law to report issues, such as serious threats to public health or safety. For example, if you indicate that you or someone else is at imminent risk of harm (for example suicide or serious threats toward the wellbeing of others), we will need to contact the appropriate authorities to protect you or the public.

Option B

• Procedures (when surveys are anonymous): We don’t keep your name with your survey. If you tell us that you are thinking about hurting yourself or someone else in your survey answers, we won’t be able to contact you. Please tell someone who can help right away. You can call the toll-free 24-hour National Suicide Prevention Lifeline at 988 to talk to a counselor near you. If you do not need help right away but would like to talk to someone about the problems you might be having, you can find help by contacting someone from the attached resource* document.
• Procedures (when offer of resources only): As part of the research, we may ask questions about how you feel mentally and emotionally. As researchers, we do not provide mental health services. Also, it is possible that we will not view your answers for several days or weeks after you complete the surveys. If you are thinking about hurting yourself or someone else, please tell someone who can help immediately. You can call the toll-free 24-hour National Suicide Prevention Lifeline at 988 to talk to a counselor near you. If you do not need help right away but would like to talk to someone about the problems you might be having, you can find help by contacting someone from the attached resource* document.

William & Mary PARTICIpant Resource document

The webpage can be printed out to distribute easily for in-person participants.